BEBAC   Ing. Helmut Schütz

EMA

Guideline on the Investigation of Bioequivalence

The new Guideline (CPMP/QWP/EWP/1401/98 Rev. 1) was adopted by CPMP on 20 January 2010 and published on 29 January 2010.
The Guideline is effective with 01 August 2010.

This guideline replaces the “Note for guidance on the investigation of bioavailability and bioequivalence” CPMP/QWP/EWP/1401/98 and the related Q&A document (CHMP/EWP/40326/06).
This guideline includes recommendations on BCS-based biowaivers.

A separate document (EMA/CHMP/EWP/26817/2010: 248 pages, 1.5MB) presenting comments received by EMA on the draft guideline was published on 10 February 2010.

BEBAC